NL-OMON46851
Completed
Phase 2
The application of contrast-enhanced ultrasound to facilitate thrombolysis in patients with acute peripheral arterial occlusions. - MUST Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Men and women older than 18 years and younger than 85 years old
- •\* Patients with a maximum of 2 weeks complaints due to lower limb ischemia due to
- •thrombosed/occluded iliofemoral, femoropopliteal or femorocrural native arteries or femoropopliteal or
- •femorocrural venous or prosthetic bypass grafts
- •\* Anatomic suitability duplex ultrasound in case of iliac occlusion
- •\* Patients fit for thrombolysis i.e. with acute lower limb ischemia class I and IIa according to the
- •Rutherford classification (see attachment II)
- •\* Patients understand the nature of the procedure and provide written informed consent before enrolment
- •in the study
Exclusion Criteria
- •\* Patients with clinical complaints of acute lower limb ischemia due to thrombosis of the iliofemoral, femoropopliteal or femorocrural native arteries, or femoropopliteal or femorocrural venous or prosthetic bypass grafts more than 2 weeks
- •\* Patients with iliac occlusions anatomically not suitable for duplex ultrasound
- •\* Patients with thrombosed popliteal aneurysms
- •\* Patients with contra\-indications for the administration of antiplatelet therapy, anticoagulants or thrombolytics
- •\* Recent (less than 6 weeks) ischemic stroke, cerebral bleeding or myocardial infarction
- •\* Patients with recent (less than 6 weeks) surgery
- •\* Severe hypertension (diastolic blood pressure greater than 110 mm Hg, systolic blood pressure higher than 200 mm Hg)
- •\* Current malignancy or severe comorbid condition with a life expectancy of less than 6 months
- •\* Patients with uncorrected bleeding disorders (gastrointestinal ulcer, menorrhagia, liver failure)
- •\* Women with child\-bearing potential not taking adequate contraceptives or currently breastfeeding
Outcomes
Primary Outcomes
Not specified
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